DBEST REAGENT STRIP FOR URINALYSIS

K973142 · Ameritek, Inc. · JIL · Oct 20, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973142
• Device Name: DBEST REAGENT STRIP FOR URINALYSIS
• Applicant: Ameritek, Inc.
• Product Code: JIL · Clinical Chemistry
• Decision Date: Oct 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended Use

dBest reagent strip for Urinalysis. Ketone, specific gravity, leukocytes in the Urine.

Device Story

dBest reagent strip is an in vitro diagnostic device used for urinalysis. It consists of reagent-impregnated pads on a strip that undergo color changes upon contact with specific urine analytes (ketones, specific gravity, leukocytes). The device is intended for use by healthcare professionals or patients to screen for metabolic or urinary tract conditions. The user compares the color of the reacted pads against a standardized color chart provided with the product to determine the concentration or presence of the analytes. This visual assessment aids in clinical decision-making regarding patient health status and the need for further diagnostic testing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reagent strip for urinalysis; colorimetric chemical reaction principle; visual readout via color comparison chart; non-electronic; no software.

Indications for Use

Indicated for the qualitative or semi-quantitative detection of ketones, specific gravity, and leukocytes in urine samples.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 20 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

K.C. Yee, Ph.D. AmeriTek, Inc. 7030 35th Avenue, N.E. Seattle, Washington 98115

Re: K973142 dBest Reagent Strip for Urinalysis Regulatory Class: I, II Regulacory Crabb: "IIN, JMT, CEN, JIR, CDM, JIO, JRE, JJB, LJX August 18, 1997 Dated: August 21, 1997 Received:

Dear Dr. Yee:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marice is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register.

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{1}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

CDRH ODE

K973142
003

Page 2 of Two

N/A 510(k) Number (if known):

Device Name: dBest reagent strip for Un

Indications For Use:

/28/97

naly 5.42 Ketone, specific grav 1 1310 uKocytes in the Uring Uro be ren ut 6 17

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

ਾ

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Clinical, Laboratory Devides 2.
510(k) Number